טופיתרים 100

ישראל - עברית - Ministry of Health

קנה את זה

עלון מידע עלון מידע (PIL)

28-11-2020

מרכיב פעיל:
TOPIRAMATE
זמין מ:
TRIMA ISRAEL PHARMACEUTICAL PRODUCTS MAABAROT LTD
קוד ATC:
N03AX11
טופס פרצבטיות:
טבליה
הרכב:
TOPIRAMATE 100 MG
מסלול נתינה (של תרופות):
פומי
סוג מרשם:
מרשם נדרש
תוצרת:
TRIMA ISRAEL PHARMACEUTICAL PRODUCTS MAABAROT LTD, ISRAEL
קבוצה תרפויטית:
TOPIRAMATE
איזור תרפויטי:
TOPIRAMATE
סממני תרפויטית:
In adjunctive therapy of adults and children (from 2 years) with partial seizures and generalized tonic-clonic seizures. In adjunctive therapy of seizures with Lennox-Gastaut syndrome in adults and children. Topitim is indicated as monotherapy in patients with newly diagnosed epilepsy in children aged 7 years and above or for conversion to monotherapy in patients with epilepsy. Topitrim is indicated in adults for the prevention of migraines. The use of Topitrim in the acute treatment of migraine has not been studied.
leaflet_short:
א. התרופה תינתן לטיפול באפילפסיה , ורק אם החולה אינו מאוזן על ידי טיפול בתרופה אנטי אפילפטית אחרת, כגון : Carbamazepine, Valproic acid, Phenytoin, Primidone. ב. מתן התרופה ייעשה לפי מרשם של רופא מומחה בנוירולוגיה
מספר אישור:
136 65 31516 00
תאריך אישור:
2012-04-30

מסמכים בשפות אחרות

עלון מידע עלון מידע - אנגלית

17-08-2016

עלון מידע עלון מידע - ערבית

28-11-2020

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0512H

±∏≥

Topiramate25 mg, 50 mg, 100 mg, 200 mg

Lactose 17 mg, 34 mg,68 mg, 136 mg

Sodium 0.1 mg, 0.2 mg, 0.4 mg, 0.8 mg

PATIENT PACKAGE INSERT IN ACCORDANCEWITH

THEPHARMACISTS’REGULATIONS(PREPARATIONS)-1986

TOPITRIM

25 mg,50 mg,100 mg,200 mg

Tablets

The dispensing of this medicine requires a doctor’s prescription

Read this package insert carefully in its entirety before using this medicine

Composition:Each tablet contains:

Topiramate 25 mg, 50 mg, 100 mg, 200 mg

and also lactose 17 mg, 34 mg, 68 mg, 136 mg, respectively.

and also sodium 0.1 mg, 0.2 mg, 0.4 mg, 0.8 mg, respectively.

Inactive ingredients: Lactose monohydrate,microcrystalline cellulose, pregelatinised starch,

sodium starch glycollate,magnesium stearate, hydroxypropyl methylcellulose, titanium

dioxide, polyethylene glycol

Therapeutic group:Antiepileptics (anticonvulsants).

Therapeutic activity:An antiepileptic medicine for use in combination with other medicines

in adults and in children from two years of age and above, or as monotherapy in adults and

in children from seven years of age and above.The medicine is indicated for prevention

of migraine in adults.The medicine is not intended for pain relief caused byacute migraine.

When should the preparation not be used?

Do not use this medicine if you are breastfeeding.Do not use this medicine if you are

sensitive to any of its ingredients.Do not use this medicinefor migraine prevention if you

are planning to become pregnant or are pregnant.

Do not take this medicine without consulting a doctor before starting treatment:

If you are suffering from epilepsy and you are pregnant or planning to become pregnant,

refer to the doctor in order to receive another medical treatment for your disease.If you are

of childbearing age refer to the doctor for advice about the necessity of another medication.

If you haverecently undergone or are scheduled to undergo surgery soon.If you have

diarrhea.If you are on a ketogenic diet (low in carbohydrates and high in fats).If you are

suffering, or havesuffered in the past, from epilepsy of status epilepticus type, from severe

impaired function of the respiratory system, from impaired function of the eyes (e.g.

glaucoma), the liver, the kidney/urinary tract or if a family member suffers from kidney stones.

How will this medicine affect your daily life?

This medicine may impair alertness and therefore caution should be exercised when

engaging in activities such as driving a car,operating dangerous machinery and in any

other activity which requires alertness.Children should be cautioned against engaging

in activities such as bicycle riding or playing near roads and the like.

Donotdrinkwine or other alcoholic beverages when taking this medicine.

Do not follow a ketogenic diet (low in carbohydrates and high in fats) during the treatment

withTopitrim.

Warnings:The use of this medicine during pregnancy increases the risk of having babies

with cleft palate and/or lip.This medicine may cause blurring of vision.If you are sensitive

to any type of food or medicine, inform your doctor before commencing treatment with this

medicine.Pay attention to any evidence of a decrease in sweating and an increase in body

temperature, especially in children, particularly in hot climate regions.Inform your doctor

if you haverecently undergone surgery or if you are about to undergo surgery.Inform your

doctor about any case of diarrhea during treatment withTopitrim.Your doctor may instruct

you to undergo blood tests to assess the bicarbonate level in your blood before and during

treatment withTopitrim.

Taking antiepileptic medicines (anticonvulsants) may increase the risk of having suicidal

actions or thoughts.You and your family members should pay close attention to any changes

in mood and behavior patterns.Watch daily for common warning signs that might be a

signal for risk of suicide such as:talking or thinking about wanting to hurt yourself, introversion

and withdrawing from friends and family, becoming depressed or having your depression

get worse, becoming preoccupied with death and dying, giving awayprized possessions.

If one or moreof the above signs or any other worrisome behavior pattern occur -

contact your doctor immediately!

The tablets contain lactose and may cause an allergy in people sensitive to lactose.

Drug interactions:If you are taking another drug concomitantly or if you havejust finished

treatment with another medicine, inform the attending doctor, in order to prevent hazards

or lack of efficacy arising from drug interactions.This is especially important for medicines

belonging to the following groups:drugs affecting the central nervous system (e.g.sedatives,

hypnotics, drugs for treatment of epilepsy - excluding lamotrigine), antihypertensives of the

hydrochlorothiazide (diuretic) type or propranolol (a beta-blocker antihypertensive), digoxin

arrhythmias).Avoid using medicines containing acetazolamide (a mild diuretic of the carbonic

anhydrase inhibitor group used mainly for treatment of glaucoma), triamterene, or taking

large quantities (more than 2 grams) of vitamin C.Metformin (a biguanide used for lowering

blood glucose levels), and pioglitazone (a thiazolidinedione used for lowering blood glucose

levels) - for treatment of diabetes.The efficacy of contraceptives may be impaired.

If there is a change in your menstrual cycle, refer to the attending doctor.

Side effects:In addition to the desired effect of the medicine, adverse reactions may occur

while taking this medicine, for example:headache, nausea, drowsiness, diarrhea, dizziness,

buzzing in the ears, debilitation, abdominal pain, depression, tingling sensation, confusion,

weakness, nervousness and mood changes, memory problems.

Other side effects that may appear when treating migraine (prophylaxis):numbness,

indigestion, insomnia, taste perversion, dryness of the mouth.

Side effects that require special attention: Speech disturbances (rare):refer to the doctor.

Disturbed concentration, movement disturbances,cognitive disturbances, kidney stones,

confusion, weight loss:refer to the doctor.If there is a change in your menstrual cycle

(breakthrough bleeding):please refer to the attending doctor.Symptoms indicating metabolic

acidosis (e.g.:fatigue, loss of appetite, irregular heartbeat, cloudy consciousness):refer

to the doctor immediately! Sudden vision disturbances, sudden blurring of vision, eyepain,

or redness of the eyes:refer to the doctor immediately!These effects may be caused by

increased intraocular pressure and, if not treated immediately, may lead to loss of sight.

Decreased sweating and an increase in body temperature:refer to the doctor.In the event

that you experience side effects not mentioned in this leaflet, or if there is a change in your

general health, consult your doctor immediately.

Adverse reactions and drug interactions in children and infants:Parents must informthe

attending doctor about any side effects, as well as any additional medicine being taken bythe

child! See abovefor details of special side effects and drug interactions.Pay special attention

to a decrease in sweating and an increase in body temperature in children and infants.

Dosage:Dosage is according to doctor’s instructions only.

Do not exceed the recommended dosage.

This medicine is not intended for administration to children and infants below 2 years

of age, and as monotherapy, below 7 years of age.

This medicine is to be taken at specific time intervals as determined bythe attending doctor.

If you forget to takethis medicine at the specified time,takethe dose as soon as you

remember, but if it is almost time for the next dose, do not take the missed dose and continue

with the regular dosing schedule.Do not take two doses together!

Attention:Be sure that the amount of sweating and/or body heat havenot changed,

especially in hot weather.

Directions for use:Do not chew! Swallow the medicine with a large amount of water,

especially in hot weather and/or when participating in physical activity.This medicine can

be taken with/after food or between meals.Children under 6 years of age havedifficulty

swallowing whole tablets, and this can sometimes be hazardous;the tablet therefore should

be crushed and taken immediately.Donot halve the tablet.

How can you contribute to the success of the treatment?

Complete the full course of treatment as instructed bythe doctor.

Even if there is an improvement in your health, do not discontinue use of this medicine

without consulting your doctor.If the doctor has recommended to discontinue the treatment,

it should be done gradually.Be sure to drink liquids while under treatment in order to reduce

the risk of formation of kidney stones.

Avoidpoisoning!This medicine, and all other medicines, must be stored in a safe place

out of the reach of children and/or infants, to avoid poisoning.If you havetaken an overdose,

or if a child has accidentally swallowed the medicine, proceed immediately to a hospital

emergency room and bring the package of the medicine with you.Donotinducevomiting

unless explicitly instructed to do so bya doctor!This medicine has been prescribed for the

treatment of your ailment;in another patient it may cause harm.Do not give this medicine

to your relatives, neighbors or acquaintances. Donottakemedicinesinthedark! Check

the label and the doseeachtime you take your medicine.Wear glasses if you need them.

Storage:Store in a dry place, below 25 0 C.Even if kept in their original container and stored

as recommended, medicines may be kept for a limited period only.Please note the expiry

date of the medicine! In case of doubt, consult the pharmacist who dispensed the medicine

to you.Do not store different medicines in the same package.

License number:

Topitrim 25 mg: 136 63 31514 00 Toptrim 50 mg: 136 64 31515 00

Topitrim 100 mg: 136 65 31516 00 Topitrim 200 mg: 136 66 31517 00

The format of this leaflet was determined by the Ministry of Health and its content was

checked and approved by it

Maabarot 40230

Israel Pharmaceutical Products

Maabarot Ltd. 0512H

±∏≥

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